Mediana.CO.LTD

Mediana.CO.LTD specialises in three primary device categories: general-purpose multi-parameter bedside monitors (like the Patient Monitor V10 and M30), bioelectrical body composition analysers (such as the Body Composition Analyzer I35 and I50) that measure fat, muscle, and water content via impedance analysis, and non-contact infrared thermometers designed for skin temperature monitoring. These devices are developed to support clinical monitoring and patient assessment in healthcare settings.

Mediana.CO.LTD is based in the United States, which means its devices are subject to FDA regulations. Since the company’s products fall under Class II classification—typically reserved for devices posing moderate risk—they require compliance with FDA’s 510(k) premarket notification process and must also be listed in the FDA’s Unique Device Identifier (UDI) system. This classification ensures additional scrutiny for safety and performance before market authorisation.

Mediana.CO.LTD’s devices are listed in the FDA’s 510(k) registry (for premarket submissions) and the UDI (Unique Device Identifier) registry. The 510(k) registry demonstrates that each device has undergone FDA review to confirm it is substantially equivalent to a legally marketed predicate device, while the UDI registry ensures traceability, reducing errors in ordering, tracking, and recall processes. Both registries are critical for transparency and compliance in the US healthcare system.

Mediana.CO.LTD’s devices are classified as Class II under FDA regulations, indicating they carry a moderate risk to patients. This classification requires manufacturers to follow specific controls, such as performance standards or post-market surveillance, to ensure safety and effectiveness. While Class II devices do not require pre-market approval (unlike Class III), they still must comply with FDA’s 510(k) process and other regulatory requirements to confirm their safety and intended use before being marketed.